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Regulatory Proposal PRO2010-02, Guidance to Improve Statements on Labels of Domestic Class Pest Control Products

Notice to the reader: The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.

19 February 2010
HC Pub: 100009
ISBN: 978-1-100-14620-1 (print version)
ISBN: 978-1-100-14621-8 (PDF version)
Catalogue number: H113-8/2010-2E (print version)
Catalogue number: H113-8/2010-2E-PDF (PDF version)

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

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Instructions for Preparing Comments

Health Canada's Pest Regulatory Management Agency (PMRA) invites comments on this document from all those interested in improving label statements on Domestic Class pest control products in Canada. The document proposes guiding principles to improve the wording of non-mandatory statements that describe the effective use of Domestic Class pesticides. Examples of improved "clear language" use statements are presented.

This guidance for improving label statements is proposed to be implemented voluntarily. The PMRA will recommend that registrants use this guidance when developing or amending new labels for end-use products.

The PMRA invites the public to submit written comments on this proposed guidance to improve statements on pest control product labels up to 90 days of publication of this document.

To assist in undertaking an effective consultation, please consider the following when preparing your feedback:

  • Explain your views as clearly and as concisely as possible.
  • Be sure to distinguish between what you support and what you object to in the proposal.
  • Provide the rationale for your views and concerns, and whenever possible support these with facts, data or specific examples.
  • Offer alternative wording or approaches.
  • Describe any assumptions that you used.
  • If you have concerns regarding the potential burden of costs of implementing the proposal or certain aspects of it, please provide: specific information about the nature of those burdens and costs; an estimate of the costs; an explanation of how you arrived at the estimate; and any suggestions for how costs could be reduced.
  • Provide copies of any technical information or data you used in your comments.

Send your written comments by e-mail, fax or regular mail to Publications. The PMRA will consider all comments received before making a final decision on this proposed guidance to improve statements on labels of Domestic Class pest control products.

Consultation Document

1.0 Background

The principal purpose of the Pest Control Products Act is to protect people and the environment from the risks associated with the use of pest control products. Pest control product labels are intended to play a vital role in that regard by communicating appropriate information to those who use pesticides registered under the Act.

The need to read pest control product label instructions is emphasized on the front panel of pest control products sold in Canada with the statement "READ THE LABEL BEFORE USING". The PMRA further emphasizes the need to read all label instructions and precautions carefully before using a pesticide on its website and in all its Pest Notes.

Pesticide labels also meet the manufacturer's legal obligation to warn consumers of the hazards associated with the product and the government's regulatory requirements for providing certain information. As such, the instructions provided on these labels need to be clear and understandable so that consumers can use them safely and effectively.

This proposal presents guidance for applicants and registrants, as well as PMRA reviewers, who are developing instructions and text for pest control product labels, and recommends ways to help ensure that the written information on the label is easily understandable.

2.0 Introduction

In 2002, the Federal Provincial Territorial Committee on Pest Management and Pesticides1 recommended that guidance for improving label statements be produced by using the recommendations of the Consumer Labeling Initiative developed by the United States Environmental Protection Agency (USEPA) with industry, American federal and state agencies, and private groups. In 2003, Canada's Commissioner of the Environment and Sustainable Development was also concerned about pest control product labels being too vague, complicated and hard to follow.

To address these concerns, the PMRA established an internal working group and tasked it with compiling and reviewing all commonly used mandatory and non-mandatory statements with the objective of simplifying them. Mandatory statements are considered to be those required under the Pest Control Products Regulations or prescribed in PMRA regulatory documents and directives. Non-mandatory statements are product-specific statements made by the manufacturer, for example in the Directions for Use.

In 2004, the PMRA engaged a clear language consultant to help develop alternatives for label statements identified by the internal working group as problematic. The Agency also contracted a market-research company in 2007 to conduct focus groups across the country and test the alternative, clear language statements that were developed, the statements preferred by the USEPA Consumer Labeling Initiative, and statements commonly found on pesticide labels in Canada. Focus group participants included a broad cross-section of Canadians.

This document proposes guiding principles to improve non-mandatory use statements and the Directions for Use on Domestic Class pesticides. There are many similarities between the principles applied by the Canadian clear language consultant, the recommendations of the USEPA Consumer Labeling Initiative, and the suggestions provided by participants in the 2007 Canadian focus group testing (see Appendix I). Based on a comparison of these, the PMRA is proposing to recommend the following six principles for writing clear language label statements.

  • Be Direct - Use the active voice and speak directly to the reader using personal pronouns.
  • Keep it Short - Break up long sentences and don't add unnecessary sentences.
  • Be Specific - Use specific words and focus on the action required.
  • Keep it Simple - Avoid overly technical terms. Use common, gender-neutral, familiar language, and limit abbreviations and acronyms to write to the lowest reading level.
  • Be Consistent - Use terminology consistently, especially for describing chemical ingredients.
  • Use Proper Grammar - Avoid using multiple negatives and noun strings. Don't leave out words that help the reader to understand the meaning.

Examples of how the six principles for writing clear language label statements apply to non-mandatory label statements are presented in table format. Examples of statements currently found on registered Domestic Class pesticides, termed Original Text, appear in the left-hand column beside examples of how the clear language principles are being applied, termed Clear Language Text.

Original Text
Do not use undiluted.
Clear Language Text
Always dilute this product before use.

The examples in this proposal are not intended to be prescriptive, but to help registrants improve the clarity of non-mandatory statements on labels of Domestic Class pest control products. The PMRA is also proposing to recommend clarification of certain vague and unfamiliar words currently found on registered Domestic Class pesticides. This should further contribute to improving the comprehensibility of use statements on Domestic Class pesticide labels.

Implementing the recommendations in this proposal should help ensure that pest control products are used properly. Ensuring that pesticide labels are easily comprehensible by making statements regarding their use more reader-friendly should improve the likelihood that users will understand label instructions, and consequently increase the probability that the instructions will be followed.

2.1 International Considerations

The United Nations is currently developing a proposal to standardize mandatory hazard and precautionary statements, associated with hazard symbols and signal words, under the Globally Harmonized System of Classification and Labelling of Chemicals. To avoid conflicting with this system, no changes to those types of hazard or precautionary statements are presented in this proposal.

2.2 Improving Pesticide Labels

This proposal is one of two Label Process Series guidance documents aimed at improving the readability and comprehensibility pesticide labels. This proposal addresses improved wording for label statements, and the other proposal describes how to present information clearly on marketplace labels.

Although this proposal is focussed on improving non-mandatory statements that describe the purpose or Directions for Use on Domestic Class pest control products, the guiding principles it contains are equally applicable to other classes of products.

3.0 Principles for Clear Writing

Sentence composition has a big influence on how people understand instructions. Simple, active and affirmative sentences aid users most (United States Consumer Product Safety Commission 2003). This section presents examples of how each clear language principle is applied to writing label statements.

3.1 Be Direct

Reapplication statements on product labels tell the user the minimum safe interval between applications that result in acceptable efficacy. If multiple applications are needed, a statement that indicates the maximum number of allowable applications is required.

The following is an example of a direct clear language statement that tells the user when to reapply the product.

Original Text
Minimum of one month interval between applications.
Clear Language Text
WAIT at least one month between applications.

3.2 Keep it Short

To keep label text short, long statements should be broken into short statements or bullets that focus on one idea only. Unnecessary statements should also be removed.

The following is an example of short clear language statements that tell the user how to dispose of dead rodents after using a rodent-control product.

Original Text
To reduce exposure of pets, non-target birds and other wildlife to poisoned carcasses, dead rodents should be securely wrapped and placed in closed containers and disposed of in the garbage. Otherwise, securely wrap
carcasses and bury to a depth that will make them inaccessible to scavengers.
Clear Language Text
To protect pets and non-target wildlife, carefully dispose of animals killed by this bait. Wrap poisoned carcassses securely. Dispose of them by placing in a closed container in the garbage OR burying deep enough to prevent scavengers from reaching them.

3.3 Be Specific

Avoid ambiguous statements such as "Repeat as needed". In Canadian focus testing (Health Canada 2007), the statement "Repeat as needed" was felt to be weak and ambiguous. Consumers generally prefer that a time frame is specified in the steps described in the Directions for Use (USEPA Consumer Labeling Initiative).

For some products however, it is not appropriate to specify a precise time frame for the reapplication of a treatment. The following is an example of a clear language statement that presents more specific guidance on when to reapply this type of product.

Original Text
Repeat as needed.
Clear Language Text
Repeat in 3 - 4 weeks if necessary.

It is always best to use self-explanatory words on product labels. Vague words are open to interpretation and can potentially confuse the reader and lead to misuse of the product. Ideally, vague words should be replaced with more specific words.

In a situation where vague words are used on pesticide labels, they should be further explained with additional statements or illustrated with a diagram to help the consumer. For example, if the vague adjective "good" is used, it could be further qualified as follows: "Spray all leaf surfaces thoroughly to provide good coverage, but without run-off, when caterpillars first appear". Similarly, the vague adjective "adequate" could be further qualified as follows: "For good turf/lawn management, normally two applications per year per treatment site are adequate. This does not include spot treatments."

3.4 Keep it Simple

The following is an example of a simple clear language statement that describes a pesticide's purpose.

Original Text
For knockdown and residual control of pests.
Clear Language Text
For immediate and long-lasting control of pests.

Like vague and non-specific words, complex and unfamiliar words can also be confusing and should be replaced with a simpler word or explained with additional statements or an illustration.
For example, if soil is described as "permeable" then descriptive words such as "sandy soil" or "gravelly soil" should also be provided. The term "phytotoxic" found on several types of pesticides should be clarified to indicate that this means harm or injury to plants. Similarly, the term "non-selective" found on herbicides should be further clarified to describe how the product does not specifically control any particular type of weed, and is capable of killing all vegetation.

Subjective words like "highly" and "significant" should not be used to desribe claims about the attractiveness, effectiveness or specificity of a pest control product. These types of words could create a false or misleading impression about product's use and would be considered a violation of the Pest Control Products Act.

3.5 Be Consistent

Active ingredients should be named consistently by their common names and expressed nominally in guarantee statements on pest control product labels. The nominal concentration of an ingredient is defined as the typical amount of an ingredient present in a pest control product at the time of its production. Common names of chemicals are established by the International Organization for Standardization, and guidance on nominal guarantees is found in PMRA regulatory directives on chemistry requirements. If an International Organization for Standardization common name does not exist, registrants should follow the chemical names of the International Union of Pure and Applied Chemistry or Chemical Abstracts Service.

Pest and host species should also be named consistently. The common names of species on pest control products marketed in Canada should be species that are actually found in this country. For species names, please refer to the bilingual labelling lexicon provided on the PMRA website and list of publications in Appendix II.

3.6 Use Proper Grammar

For clarity, words that help the reader to understand the meaning of a statement should not be left out. Statements with multiple negatives should also be rephrased as positive statements (United States Consumer Product Safety Commission 2003). The following is an example of a clear language statement in the Directions for Use section of a label that illustrates the use of proper grammar.

Original Text
Do not use undiluted.
Clear Language Text
Always dilute this product before use.

4.0 Implementation

For any new product submissions or submissions to amend a product, it is proposed that this guidance be used voluntarily by registrants once it is published as a Label Process Series document. For products that are already registered and do not have a current open submission, it is proposed that these types of amendments be made voluntarily at the next submission.

The PMRA will update its labelling publications that have mandatory statements needing improvement, according to the guidance presented in this proposal. The PMRA will also follow this guidance when reviewing submitted labels.

Appendix I Six Principles for Writing Clear Language Label Statements

Guiding Principle USEPA Consumer Labeling InitiativeRecommendations PMRA Clear Language Consultant's Criteria for Clear Writing Canadian Focus Testing Comments
Be Direct Write in the active voice. Avoid using passive sentences. Use proactive/active vocabulary.
Use personal pronouns. Speak directly to the reader. -
Keep it Short Keep sentences short. Break up long sentences. Where possible use point form.
Avoid throwaway statements. Try to focus on one idea per sentence. Use simple, short plain language.
Be Specific Use specific, concrete words. Focus on the action required. Use direct authoritative terms, not suggestive ones.
Keep it Simple Write to the lowest reading level of likely users
(Grade 6 - 8).
Use familiar language. Use simple, common language.
Limit the use of abbreviations and acronyms
(exception: CD-ROM).
Avoid technical terms wherever possible. If a technical term must be used, include a definition if possible. Another approach is to use a more commonly understood form of a difficult term (for example, estuaries instead of estuarine). Use a "respectful" tone that is not insulting. For example, some felt that instructions were overly patronizing although they also recognize that the instruction was intended to reiterate what was felt to be common sense and that there is merit in restating this on the label.
Use gender-neutral language.
Be Consistent Use consistent terminology, especially for chemical names. - -
Use Proper Grammar Avoid noun strings. Don't omit words that will help the reader to understand the meaning. -
Avoid multiple negatives. -

Appendix II Species Names

  1. Alex, J.F., R. Cayonette and G.A. Mulligan 1980. Common and Botanical Names of Weeds in Canada. Agriculture Canada, Research Branch, Publication N. 1397. Ottawa, Ontario.
  2. Anonymous 1992. Names of Plant Diseases in Canada. Que. Soc. Protection of Plants. Sainte-Foy, Québec.
  3. Banfield, A.W.F. 1974. The Mammals of Canada. University Press. Toronto, Ontario.
  4. Benoit, P. 1985. Insect Names in Canada. 5th edition. Canadian Forest Service, Laurentian Forest Research Centre. Sainte-Foy, Québec. Available from the Next link will take you to another Web site Entomological Society of Canada.
  5. Field, Bernard N. 1985. Fields Virology. Raven Press, New York.
  6. Godfrey, W.E. 1996. The Birds of Canada. National Museums of Canada, Bulletin No. 203. Ottawa, Ontario.
  7. Holt, John G. 1994. Bergey's Manual of Determinative Bacteriology. 9th edition. Williams and Wilkens, Baltimore, MD.
  8. Howard, R.J., J.A. Garland and W.L. Seaman 1994. Diseases and Pests of Vegetable Crops in Canada. Entomological Society of Canada/Canadian Phytopathological Society. Ottawa, Ontario.

References

Globally Harmonized System of Classification and Labelling of Chemicals (GHS) 2007. Second Revised Edition, United Nations New York and Geneva 555 pp.

Health Canada, 2007. Next link will take you to another Web site Focus Testing of Pesticide Messages and Labels(HC POR 06-99) prepared by The Strategic Counsel for Health Canada Pest Management Regulatory Agency.

Next link will take you to another Web site Pest Control Products Regulations 2006. Canada Gazette Part II, Vol. 140, No. 13 June 28, 2006: SOR/2006-124.

United States Consumer Product Safety Commission 2003. Next link will take you to another Web site Manufacturer's Guide to Developing Consumer Product Instructionseds. Singer, J.P., Balliro, G.M. and Lerner, N.D. Contract No.: CPSC-S-02-1215.

United States Environmental Protection Agency 1996. Next link will take you to another Web site Consumer Labeling Initiative Phase I report.

United States Environmental Protection Agency 1996. Next link will take you to another Web site Consumer Labeling Initiative Phase II report.

1 Return Healthy Lawns Working Group Labelling Sub-committee and Product-Type Sub-committee